Actively Recruiting
Phase I, Open-labeled, Dose-escalation, Dose-expansion Study Evaluating the Safety, Tolerance, Pharmacokinetics, and Activity of IUAb190708 in Patients With Advanced or Recurrent Solid Tumors
Led by Jun Zhou · Updated on 2026-05-13
90
Participants Needed
6
Research Sites
210 weeks
Total Duration
On this page
Sponsors
J
Jun Zhou
Lead Sponsor
F
Fudan University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is to evaluate a novel cytotoxic anti-PD-L1, IUAb190708, for the treatment of tumor
CONDITIONS
Official Title
Phase I, Open-labeled, Dose-escalation, Dose-expansion Study Evaluating the Safety, Tolerance, Pharmacokinetics, and Activity of IUAb190708 in Patients With Advanced or Recurrent Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult males or females aged 18 to 75 who understand and voluntarily sign informed consent
- Diagnosed with metastatic or locally advanced solid tumors with no effective treatment available or unsuitable/refusing standard treatment
- Positive PD-L1 expression required for certain tumors depending on study phase
- Able to provide fresh or archived tissue samples
- At least one measurable tumor lesion per iRECIST criteria
- Life expectancy of 3 months or more
- ECOG Performance Status of 0 to 1
- Adequate organ function with no recent blood transfusions, erythropoietin, or granulocyte colony-stimulating factor within 14 days
- Women of child-bearing potential must have a negative pregnancy test and agree to use effective contraception; male partners must also agree to use contraception from consent until 6 months after last dose
You will not qualify if you...
- Serious or active infection requiring intravenous antibiotics within 4 weeks before first dose
- Recent use of nitrosourea, mitomycin C, oral fluorouracil derivatives, small molecule targeted drugs, endocrine therapy, immunotherapy, traditional Chinese medicine, chemotherapy, radiation, or biotherapy within specified time frames before first dose
- Other primary active malignant tumors within 5 years prior to first dose
- Significant cardiovascular diseases
- Untreated or unstable primary CNS tumors or CNS metastases requiring steroids or other treatments
- Allergy or hypersensitivity to study drug or excipients
- History of allogeneic organ transplant
- HIV or other immunodeficiency infections
- Serious psychiatric or medical conditions interfering with adherence
- Systemic corticosteroid or immunosuppressive therapy within 2 weeks before first dose, except certain topical or short-term uses
- Active autoimmune diseases requiring systemic treatment within 2 years, except stable type I diabetes or autoimmune hypothyroidism
- History of certain lung diseases or active pneumonia
- Previous severe immune-related adverse events from immunotherapy
- Unresolved adverse effects from previous cancer treatments
- Major surgery within 4 weeks before first dose or planned surgery during study participation
- Positive for certain infections such as syphilis or active hepatitis B or C
- Other clinical or laboratory conditions deemed unsuitable by investigator
- Pregnant or breastfeeding women
- History of serious systemic diseases deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Fujian Cancer Hospital
Fuzhou, Fujian, China
Actively Recruiting
2
Anyang tumor hospital
Anyang, Henan, China
Actively Recruiting
3
Cancer hospital of Shandong First Medical University
Jinan, Shandong, China
Actively Recruiting
4
Fudan University Shanghai cancer center
Shanghai, China
Actively Recruiting
5
Shanghai Pulmonary hospital
Shanghai, China
Actively Recruiting
6
Shanghai Xinhua hospital
Shanghai, China
Actively Recruiting
Research Team
J
Jun Zhou, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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